Non-small cell lung cancer
Conditions
Interventions
Group of Elemene combined with Docetaxel therapy(3:500mg Elemene + 500 ml normal saline intravenous dripping for 2 hours, chemotherapy Part 1-14 days delivery. The next week and then one cycle of trea
Control:Docelaxel 75mg/m2, the first day of a cycle of 21 days, at least the completion of 4 cycles
Sponsors
Oncology of Beijing Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Understand the purpose of this study and signed informed consent form; 2. Age 18-75 years old, by the pathology and / or cytological proven non-small cell lung cancer; 3. Council in patients with advanced or metastatic (stage III/IV) can not accept surgery. Previously received at least 1, but not more than two times platinum chemotherapy with palliative treatment, past treatment of non-Cypriot Docetaxel, or one of the following conditions are met: (1) Postoperative adjuvant therapy relapsed within 6 months, can be regarded as first-line adjuvant therapy in the treatment of failure (only allowed to receive adjuvant treatment with a platinum program); (2) Applied retroactively if not limited to EGFR TKI treatment, but not more than two times platinum chemotherapy with palliative treatment, past treatment of non-Cypriot Docetaxel; (3) Unrestricted neoadjuvant chemotherapy, previous treatment of non-Cypriot Docetaxel; 4. At least one measurable lesion: by RESIST criteria, spiral CT diameter of at least 10mm, at least 20mm in diameter conventional CT; 5. Previous diagnosis of patients with brain metastases, if the clinical state of stability; 6. Previous radiotherapy field of vision is not within the target lesion, at least more than one month interval; 7. PS 0-2 pm, expected survival >=12 weeks; 8. No significant organ dysfunction, blood, liver, kidney, heart function was normal: Blood: neutrophil count >=1.5*10^9/l, platelet count>=8.5*10^9/l, hemoglobin >=9g/l; Liver function: total bilirubin =50ml/min.
Exclusion criteria
Exclusion criteria: 1. No measurable lesions; 2. An important organ dysfunction and severe heart disease, including congestive heart failure, abnormal heart rate control; 3. Difficult to control the existence of the history of mental illness; 4. Newly diagnosed central nervous system (CNS) metastasis, not after surgery or radiation therapy. Previous diagnosis of CNS metastasis and treatment, those symptoms can not be controlled; 5. Previous treatment programs containing docetaxel; 6. Pregnancy or breast-feeding women, appropriate contraceptive measures are not implemented and the possibility of pregnancy; 7. Activities of multiple primary cancer (intraepithelial carcinoma, as well as more than 5 years made no duplication, except cancer); 8. The researchers believe that other patients not suitable for entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;The quality of life evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Disease control rate of eight weeks;OS; | — |
Countries
China
Contacts
Public ContactYunzhong Zhu, Liyan Xu, Zhe Liu
Outcome results
None listed